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home > ict > spring 2016 > latin america
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International Clinical Trials

Latin America

Covering 20 countries and with a population of approximately 600 million, Latin America is one of the most ethnically diverse regions in the world. The main causes of death in Latin America are explained by sedentary habits, smoking and bad diets: ischemic heart disease, cerebrovascular disease and diabetes mellitus are only some of the results of these. However, due to recently enhanced sanitation conditions, broader access to public health system, nutrition and the reduction of infant mortality, the population as a whole is able to live longer, and with a reasonable quality of life.

For clinical research purposes, given the population dimension, it is easier to select patients with certain circumstances – like untreated medical conditions or rare diseases – when compared with North America and Europe, contributing to the region’s attractiveness for clinical research.

In 2020, the industry projects a market growth of 50%, of which almost 20% will come from Latin America, especially Brazil, Mexico and Argentina – the three main markets of medications’ purchasing. Given this fact, these are the most relevant markets in the region regarding clinical research. Currently, there are more than 970 active interventional industry studies in the region, where the three main markets – Brazil (363), Argentina (235) and Mexico (272) – are the major contributors.

Patient Enrolment


Unique to Latin America are two particular characteristics due to its geographic and climate conditions: the occurrence of several tropical diseases – such as dengue, Zika, malaria or Chagas disease – which are not found in Europe or North America; and the season inversion between the Northern and Southern hemispheres, which makes Latin America attractive for immediate patient recruitment throughout the year. Sponsors can pursue research on conditions that are tied to seasons – namely infectious diseases, allergies or seasonal viruses – thereby improving market access speed.

Furthermore, when clinical trials are conducted in this region, the cost per patient is around 70% to 80% of the cost of high-income countries. This translates to a possible 30% cost reduction in the patient recruitment process.

Regulatory Landscape


Continuous efforts have been made to harmonise approaches, where less regulated countries in the region have started to follow the steps of Brazil, Argentina and Mexico – today, all Latin American countries adhere to the ICH and Good Clinical Practice guidelines.

The guidelines of regulators may vary greatly, and it is necessary to comply with all the given standard lines for each case. Local rules are different for trial application and conduct. Normally, it requires the approval of the local Ethic Committee and the Ministry of Health, and this can be somewhat of a long process. Specifically in Brazil, recent regulatory changes aim to reduce these timelines in clinical research. This new legislation took into account the guidelines and processes from other international authorities, such as the FDA and EMA, and set a new tone for clinical research in Brazil. As a result, Brazil’s agency ANVISA takes an important step towards making the country a more competitive market for clinical research. This regulation establishes 90-day and 180-day timelines for the analysis and approval of clinical research requests.

In summary, by leveraging Latin America’s advantages – like patients’ recruitment and retention rates, high-quality professionals and the governments’ awareness for clinical research – and considering the challenges from the country’s heterogeneity, as well as having partners with strong, local expertise, sponsors can achieve successful trials in this region.

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Susana Bule is Clinical Trials Global Director at Eurotrials, a full-service CRO which covers all the steps of any clinical, translational or epidemiological research project. With over 18 years of experience in clinical research, she has extensive experience managing clinical trials in various therapeutic areas in Europe and Latin America.

Cláudia Carvalho
has been Marketing Senior Associate at Eurotrials since 2013 and is responsible for the areas of digital marketing, branding, content creation and design development.

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Cláudia Carvalho
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Susana Bule
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